Model Curriculum - Livelihoodlivelihoods.rajasthan.gov.in/content/dam/livlihood...Rapid mixer granulator (table top 1/5 L capacity), Double cone blender (5L Capacity), Remi stirrers,

Model Curriculum Production/ Machine Operator

- Life Sciences

SECTOR:

SUB-SECTOR:

OCCUPATION:

REF ID:

NSQF LEVEL:

LIFE SCIENCES

PHARMACEUTICAL, BIOPHARMACEUTICAL

MANUFACTURING

LFS/ Q 0207 Ver 1.0

LEVEL 4

TABLE OF CONTENTS

01

11

1. Curriculum

2. Trainer Prerequisites

3. Annexure: Assessment Criteria 12

Production/ Machine Operator- Life Sciences CURRICULUM / SYLLABUS

This program is aimed at training candidates for the job of a “Production/ Machine Operator – Life Sciences”, in the “Life Sciences” Sector/Industry and aims at building the following key competencies amongst the learner

Program Name Production/ Machine Operator- Life Sciences

Qualification Pack Name & Reference ID. ID

Production/ Machine Operator – Life Sciences LFS/ Q 0207 Ver1.0

Version No. 1.0 Version Update Date 28 – 12 – 2015

Pre-requisites to Training Minimum qualification – 10+2/ ITI

Training Outcomes After completing this programme, participants will be able to: • Gain knowledge about Life Sciences Industry Eco System, Regulations, GMP to

enable him/herself for establishing the Industry Standards in his/herperformance

• Gain scientific knowledge about Pharmaceutical and Bio PharmaceuticalManufacturing (Both API and Formulation), concept and procedure to operateand maintain various machines like (Reactor, Multimill, mixer, granulationmachine, coating machine etc.)

• Practice the professional Skills at workplace; like Decision Making, Planning &Organizing, Customer Centricity, Problem Solving, Objection Handling,Analytical Thinking, Critical Thinking;

• Prepare machines and accessories for the manufacturing process• Perform manufacturing operations and carry out broad level quality checks

before, in-process and post manufacturing• Ensure cleanliness in the work area/ shop floor• Carryout reporting and documentations as per SoP and GMP and GDP

guidelines• Follow the EHS norms and Maintain a health, safe and secure working

environment in the filed sciences facility

Production/ Machine Operator - Life Sciences 1

This course encompasses Six (6) out of Six (6) National Occupational Standards (NOS) of “Production/ Machine Operator – Life Sciences LFS/ Q 0207 Ver1.0” Qualification Pack issued by “Life Sciences Sector Skill Development Council”.

Sr. No.

Module Key Learning Outcomes Equipment Required

1 Orientation Module

Theory Duration (hh:mm)

10:00

Practical Duration (hh:mm)

00:00

Corresponding NOS Code Bridge Module

• Know about Life Sciences Industry, its sub-sectors

• Know about Regulatory Authorities andGovernment Policies, rules and Regulationsand their impact on manufacturing in LifeSciences Industry in India and EmergingMarkets (Both Regulated and Semi Regulated)

• Know about Standards for Manufacturing inLife Sciences like cGMP, ISO, etc.

• Understand Existing Organization in LifeSciences Industry (in context ofLarge/Medium/ Small Enterprises): TheirOrganization Structure and Benefits. Know thetypical manufacturing function in a LifeSciences organization.

• Understand the Role of a Machine/ ProductionOperator and required skills and knowledge(As per Qualification Pack) and its Career Path

Participant Manual, Power point presentation, Case Studies, Computer system, LCD Projector & Screen/ LCD Monitor, Mike, Sound System, Laser Pointer, White/ Black Board, White Board Marker/ chalk, duster, flip charts

2. Fundamentals of Pharmaceutical Production


24:00


06:00

Corresponding NOS Code LFS/N0213, LFS/N0214, LFS/N0215

• Know about Basics of Human Anatomy andPhysiology.

• Know and apply the fundamentals ofMetrology i.e Systems of weights andmeasures; like – Percentage calculations,velocity measurements, pressuremeasurements, specific gravity and viscosity,flow, level, thermal and temperature etc.

• Know about Quality Management System forProduction in Life Sciences Industry includingits introduction and importance, QC and QASystems, Productivity norms and concept ofoverall equipment efficiency (OEE)

• Know the Basic Concept of Techniques toimprove productivity (Lean and 6 sigma), andto control the rejects. Know and apply thetechniques to control and predict thebreakdown.

• Know and follow Deviation ,incident andchange control procedure and RequiredDocumentation practices by GMP and GDPnorms at shop floor

• Learn and apply the concepts of Data Integrityaligned to cGMP for activities at shop floor.

Participant Manual, Power point presentation, Case Studies, Computer system, LCD Projector & Screen/ LCD Monitor, Mike, Sound System, Laser Pointer, White/ Black Board, White Board Marker/ chalk, duster, flip charts


Sr. No.


3. Production Process for API


25:00


17:00


• Know and apply the Fundamental Science inAPI Production including Size Separation,Mixing and homogenization Process, MassTransfer, Fluid Flow, Heat Transfer, SizeReduction, Role of API in typicalPharmaceutical Manufacturing and role of APIparticle size in formulations andDetermination of Particle size of powders bySieve analysis and by optical microscope

• Know in detail and follow Production Processof API with an in depth understanding andpractical skills on following:

• Unit processes: Oxidation, Reduction,Hydrogenation, Sulfonation, Nitration, andHalogenation.

• Bulk organic chemicals as building blocks formanufacture of drugs and drug intermediates

• Catalysis and Bio catalysis in Industrialproduction.

• Downstream processes like Filtration,Centrifugation, Extraction, Evaporation,Crystallization, Drying and Size reduction

• Operations and cleaning of PharmaceuticalManufacturing Equipment for API like -Reactor, Reciever, Condensor, centrifuge, etc.

Participant Manual, Power point presentation, Case Studies, Computer system, LCD Projector & Screen/ LCD Monitor, Mike, Sound System, Laser Pointer, White/ Black Board, White Board Marker/ chalk, duster, flip charts, 50 Ltr Reactor, Reciever, Condensor, centrifuge, drier flatbed lab model, volves, Chemicals (Mandatory Solvents 14), Packaging Material, Drums, Poly Bags, Seals, Silica Gel Bags, Labels , Half Face Mask, Full Face Mask, Safety Goggles, Safety Shoes, Gum Boots, Chemical Absorbent, Self-Contained Breathing Apparatus, PVC Apron, Gloves(Nitrile, {Heat, acid, chemical} resistant, washing etc..), Lab Coat, Surgical Gloves (in Microbiology), Eye washer with sprinkler/ Manual bottle eye washer, Co2type Fire Extinguisher, ABC Type Fire Extinguisher, Material Safety Data Sheet, Various Safety Signage

4.` Production Process for Formulations


38:00


30:00


• Know in detail about Basics of Formulationsincluding Route of Drug Administration andVarious Dosage Forms like Oral Solid Dosage,Liquid Oral Dosage, Sterile Dosage,Dermatological Dosage and their relevantbenefits and practice Standard weightprocedure or standard quantity effect informulation

• Learn and apply the conceptual and practicalskills about Production process of Oral SolidDosage including Definition of Tablets andCapsules and types of tablets and capsules,Different processes of formulating tablets andcapsules like Process of Granulation,Compression, Coating, Capsule Filling,Operation and maintenance of General

Participant Manual, Power point presentation, Case Studies, Computer system, LCD Projector & Screen/ LCD Monitor, Mike, Sound System, Laser Pointer, White/ Black Board, White Board Marker/ chalk, duster, flip charts, Formats for BMR & BPR, Formats of Log Books, Format of Shift Schedule, Format of Job Cards, GMP Guidelines, Sample Labels, safety signage, Sample SoP document, GMP


Sr. No.


equipment for different processes like Process of Granulation, Compression, Coating, Capsule Filling, Excipients used in OSD, General in process checks and methods for performing these tests, determination of bulk density and tapped density of powders and calculation of Hausner’s ratio and compressibility index, performance of in-process checks for compressed tablets, filled capsules and visual inspection of coated tablets

• Learn and apply the conceptual and practicalskills of machine operations about Productionprocess of Liquid Oral Dosage coveringaspects like:

• Types of Liquid oral dosage forms, Differentprocesses of formulating liquid oral dosageforms, Machine operations and maintenanceof General equipment for different processeslike mixing, filtration, suspension preparation,emulsion, , Excipients used in liquid oraldosage forms, General in process checks andmethods for performing these tests,determination of viscosity of liquid usingoswald’s viscometer, determination of surfacetension of liquid, preparation of syrup IP andevaluation of specific gravity of syrup, inprocess checks in liquid preparations,Determination of equilibrium solubility

• To learn the conceptual and practical skills tooperate machines about Production process ofSterile Dosage covering aspects like: Types ofinjectable dosage forms, Different processesinvolved in manufacturing injectable dosageform, General equipment / machineoperations and maintenance for differentprocesses, Water for injection and otherexcipients used in injectable dosage forms,General in process checks and methods forperforming these tests, visual inspection ofampoules and vials

• Learn and apply the conceptual and practicalskills to operate machines about Productionprocess of Semi-solid Formulations coveringaspects like: Types of in semi-solid dosageforms, Different processes involved inmanufacturing semisolid dosage form,General equipment. Machine operations fordifferent processes, Excipients used inexcipients dosage form, General in processchecks and methods for performing these

Guidelines, GDP Guidelines, Compression Machine commercial- 10 Stn (Min), Coating Machine Prototype, Hardness Tester, DT Apparatus, Multimill, Airjet Cleaning Machine, Filter Press, Inline homogeniser Cum Mixer, Automatic Filling Machine , Planetary mixer(jackatted with electrical heating facility), Preparation vessel, reactor & Storage Tank, Agitator- Stirrer, Weighing balance (1.2kg, 6.0kg with printer), Rapid mixer granulator (table top 1/5 L capacity), Double cone blender (5L Capacity), Remi stirrers, Machine Hooper, Sifter, Tablet Deduster, Paste Kettle, Jet Claerner, Semi-Automatic Cap Sealing Machine, Online Inspection, Turn Table, Labelling machine, Semi-Automatic Ropp Cap Sealing Machine and screw capping machine, Tube Filling Machine Prototype, Laboratory Microscopes(40X and 100X), pH meter , Bulk density and Tapped density tester, Friabilator, Vernier calipers, Micrometer screw gauge, Scale, Hot plate with magnetic stirrer, UV Analyser (Make: Perkin elmer/shimadzu/Thermo), Mortor and Pessel (Type: Silica, SS-316L, Agate, Granite), Halogen Moisture Analyzer, Seive Shaker, Seive meshes (All grade levels like 100, 150, 200, 250 etc,..), Motor grinder, analytical balance, Pipettes (1mL, 2mL, 5


Sr. No.


tests, evaluation of different semi solid bases

• Learn and apply knowledge of Pharmaceuticalpackaging including types of packaging fordifferent dosage forms, regulatory guidelinesregarding labelling, in process checks inpackaging, visual inspection of finisheddosage forms

• Learn and practice Related Core Skills andProfessional Skills: Reading, writing, listening,speaking, Plan and organize, Critical thinking,problem solving, decision making, customercentricity

ml/10 ml), water bath, Desicattor, Dissolution Apparatus, Lab equipped with Fume Hoods, Glassware for Lab, Burrette stand with white tile, Various Cartridges, Sodium Metal in kerosine for testing

5. Ensure Cleanliness in the work area


08:00


04:00

Corresponding NOS Code LFS/N0103, LFS/N0101

• Gain and apply knowledge of differentMaterial, chemicals, manufacturing equipmentand filling lines, various equipment partslikefilters etc and their cleaning procedure as permanufacturer’s guide and follow the validationprocess of cleaning

• Gain and apply Knowledge about Electronicand Optical Sensors in laboratory equipment

• Follow the methodology for storage areainspection with methods and materialsrequired for cleaning variety of surfaces andequipment, methods to check the treatedsurface and equipment on completion ofcleaning, disposal methods for waste, used/unused solutions and relevant SOP,Procedures for reporting any unidentifiedsoiling and Escalation procedures for soils orstains that could not be removed

• Practice Related Core Skills and ProfessionalSkills at work like; Reading, writing, listeningand speaking, Critical thinking, problemsolving, decision making, customer centricity,plan and organizing.

Various types of cleaning material, chemicals, cleaning equipment, Half Face Mask, Full Face Mask, Safety Goggles, Safety Shoes, Gum Boots, Chemical Absorbent, Self-Contained Breathing Apparatus, PVC Apron, Gloves(Nitrile, {Heat, acid, chemical} resistant, washing etc..), Lab Coat, Surgical Gloves (in Microbiology), Eye washer with sprinkler/ Manual bottle eye washer, Co2type Fire Extinguisher, ABC Type Fire Extinguisher, Material Safety Data Sheet, Various Safety Signage

6. Quality Checks in Pharma/ Bio Pharma Manufacturing Operations


16:00


05:00

• Know about Pharmaceutical Science inclusiveof Organic Nomenclature System and BasicChemistry fundamentals.

• Know about Basic Analytical Chemistryfundamentals including , Balancing chemicalequations, Chemical equilibrium, Acid andbase chemistry, Stoichiometric calculations,Reduction and oxidation chemistry

• Know and apply the concept of interaction oflight with matter

• Gain basic understanding of Quality controlfunction and laboratory

Participant Manual, Power point presentation, Case Studies, Computer system, LCD Projector & Screen/ LCD Monitor, Mike, Sound System, Laser Pointer, White/ Black Board, White Board Marker/ chalk, duster, flip charts, Formats for BMR & BPR, Formats of Log Books, Format of Shift Schedule, Format of Job Cards, GMP Guidelines, Sample Labels, safety


Sr. No.



• Gain and apply the knowledge of samplepreparation, preservation and storage,handling glassware in lab and calibration ofglassware, follow the guidelines for weighingand measuring the sample as well safetyprecautions for sample handling.

• Carryout in process sampling for- API, Oralsolid dosage form, liquid oral dosage formsterile dosage form, semisolid dosage formand packaging operations

• Gain the conceptual scientific knowledge andskill of analytical equipment and operateanalytical equipment like Moisture analyser, Inprocess testing equipment, pH meter etc

• Follow SoPs and Perform pre-productionquality checks like- equipment installation,qualification and readiness, materialappropriateness and health and safety checks

• Follow SoPs and perform in process checksand activities like- requisite acceptancecriteria/ specification and met, cleanliness ofequipment, material verification, check QMSelements like CAPA management, changecontrol, incident management are followed atshop floor, check the facility upkeep,environmental condition and segregation ofmaterial is as per GMP norms.

• Perform Post manufacturing checks like- monitoring and review of batchmanufacturing and packaging records,analytical records and logs before batchrelease, follow SoP and GMP guidelines forreceipt, storage, testing, processing anddispatch of products


signage, Sample SoP document, GMP Guidelines, GDP Guidelines, Periodic Table of Elements, Chemistry lab equipment and glassware

50 Ltr Reactor, Reciever, Condensor, centrifuge, drier flatbed lab model, volves, Chemicals (Mandatory Solvents 14), Packaging Material, Drums, Poly Bags, Seals, Silica Gel Bags, Labels, Compression Machine commercial- 10 Stn (Min), Coating Machine Prototype, Hardness Tester, DT Apparatus, Multimill, Airjet Cleaning Machine, Filter Press, Inline homogeniser Cum Mixer, Automatic Filling Machine , Planetary mixer(jackatted with electrical heating facility), Preparation vessel, reactor & Storage Tank, Agitator- Stirrer, Weighing balance (1.2kg, 6.0kg with printer), Rapid mixer granulator (table top 1/5 L capacity), Double cone blender (5L Capacity), Remi stirrers, Machine Hooper, Sifter, Tablet Deduster, Paste Kettle, Jet Claerner, Semi-Automatic Cap Sealing Machine, Online Inspection, Turn Table, Labelling machine, Semi-Automatic Ropp Cap Sealing Machine and screw capping machine, Tube Filling Machine Prototype, Laboratory Microscopes(40X and 100X), pH meter , Bulk density and Tapped density tester, Friabilator, Vernier calipers,


Sr. No.


Micrometer screw gauge, Scale, Hot plate with magnetic stirrer, UV Analyser (Make: Perkin elmer/shimadzu/Thermo), Mortor and Pessel (Type: Silica, SS-316L, Agate, Granite), Halogen Moisture Analyzer, Seive Shaker, Seive meshes (All grade levels like 100, 150, 200, 250 etc,..), Motor grinder, analytical balance, Pipettes (1mL, 2mL, 5 ml/10 ml), water bath, Desicattor, Dissolution Apparatus, Lab equipped with Fume Hoods, Glassware for Lab, Burrette stand with white tile, Various Cartridges, Sodium Metal in kerosine for testing, Half Face Mask, Full Face Mask, Safety Goggles, Safety Shoes, Gum Boots, Chemical Absorbent, Self-Contained Breathing Apparatus, PVC Apron, Gloves(Nitrile, {Heat, acid, chemical} resistant, washing etc..), Lab Coat, Surgical Gloves (in Microbiology), Eye washer with sprinkler/ Manual bottle eye washer, Co2type Fire Extinguisher, ABC Type Fire Extinguisher, Material Safety Data Sheet, Various Safety Signage

7. Documentation and Reporting for Machine Operator


06:00

• Gain Complete knowledge of company’sstandard operating procedure and guidelinesand Various coding system of the company

• Apply Basic understanding of machinescontrol panel, material labels & safety signage

• Read and interpret the graphs/ images ofproduct and instructions given in tool/equipment manual, production plan andschedules, production work flow sequenceand material safety sheet

Participant Manual, Power point presentation, Case Studies, Computer system, LCD Projector & Screen/ LCD Monitor, Mike, Sound System, Laser Pointer, White/ Black Board, White Board Marker/ chalk, duster, flip charts, Formats for BMR & BPR, Formats of Log Books, Format of Shift


Sr. No.



05:00

Corresponding NOS Code LFS/N0102, LFS/N0213, LFS/N0214, LFS/N0215, LFS/N0103

• Select the right format of documentation forRecording and communicating details of workdone as per SOP and GMP and GDP guidelines

• Follow daily report format and submission asper the SOPs

• maintain record in appropriate manner• Follow the validation process of document• timely report about each and every incident

management• Understand impact of wrong practices and

inform supervisor as per SoPs and instructions• identify and report incidents where SOP are

not followed

• Identify reporting need to supervisor forfinding solutions

• Escalation matrix for decision making that isnot defined in SOP

• Read and write memos, job cards, reports likeBPR/BMR, material receipt, logs etc. in predecided format both Offline and online as perSOP

• Record & communicate the work done in locallanguage and English

• take inputs from team and make proper reportof that input

• Follow and practice efficient and clearcommunication methods for reporting theincidents and communication with team

Schedule, Format of Job Cards, GMP Guidelines, Sample Labels, safety signage, Sample SoP document, GMP Guidelines, GDP Guidelines

8. Maintain a healthy, safe and secure working environment in the pharmaceutical manufacturing facility


16:00


10:00

Corresponding NOS Code LFS/N0101, LFS/N0103

• Learn the Basic Concepts of Safety includingHazards, Accidents, Safety Signs and Signalsand Henriech Pyramid and follow and practicesame at shop floor

• Know about Water Systems at Plant,Engineering related tools and techniques tooperate the machine safely. Understand theclean room classifications and requirements,Know and follow Clean room behaviourpractices

• Use Material Data Safety Sheet, and follow theProcess of Safety Analysis. Know and follow the Fire Safety concepts and prepare oneself to act in case of Fire Emergency at shop floor. Know aboutvarious PPEs used in different production operations and do Job Safety Analysis for Various production machines/ equipment and provide these critical information to concerned team members.

Half Face Mask, Full Face Mask, Safety Goggles, Safety Shoes, Gum Boots, Chemical Absorbent, Self-Contained Breathing Apparatus, PVC Apron, Gloves(Nitrile, {Heat, acid, chemical} resistant, washing etc..), Lab Coat, Surgical Gloves (in Microbiology), Eye washer with sprinkler/ Manual bottle eye washer, Co2type Fire Extinguisher, ABC Type Fire Extinguisher


Sr. No.


• Learn and follow the Basic Concepts andpractical skills for managing EmergencyProcedures and how to do first aid


9. Information Technology Skills


12:00


24:00

Corresponding NOS Code LFS/N0102

• Apply Basic Computer Skills (Ms Office,Internet) at Work. Use Lab ManagementInformation System in a Production plant

Participant Manual, Power point presentation, Computer Lab, LCD Projector & Screen/ LCD Monitor, Mike, Sound System, Laser Pointer, White/ Black Board, White Board Marker/ chalk, duster

10. Internship


00:00


120:00

Corresponding NOS Code LFS/N0213, LFS/N0214, LFS/N0215, LFS/N0101, LFS/N0102, LFS/N0103

• Prepare machines and accessories for themanufacturing process

• Perform manufacturing operations

• Ensure cleanliness in the work area

• Carry out reporting and documentation

• Carry out broad level quality checks before, in-process and post manufacturing

• Maintain a healthy, safe and secure workingenvironment in the life sciences facility

Internship Monitoring Report

Total Duration


155:00


221:00

Unique Equipment Required: Participant Manual, Power point presentation, Case Studies, Computer system, LCD Projector & Screen/ LCD Monitor, Mike, Sound System, Laser Pointer, White/ Black Board, White Board Marker/ chalk, duster, flip charts, Computer Lab, Formats for BMR & BPR, Formats of Log Books, Format of Shift Schedule, Format of Job Cards, GMP Guidelines, Sample Labels, safety signage, Sample SoP document, GMP Guidelines, GDP Guidelines, Periodic Table of Elements, Chemistry lab equipment and glassware, 50 Ltr Reactor, Reciever, Condensor, centrifuge, drier flatbed lab model, volves, Chemicals (Mandatory Solvents 14), Packaging Material, Drums, Poly Bags, Seals, Silica Gel Bags, Labels, Compression Machine commercial-


Sr. No.


10 Stn (Min), Coating Machine Prototype, Hardness Tester, DT Apparatus, Multimill, Airjet Cleaning Machine, Filter Press, Inline homogeniser Cum Mixer, Automatic Filling Machine , Planetary mixer (jackatted with electrical heating facility), Preparation vessel, reactor & Storage Tank, Agitator- Stirrer, Weighing balance (1.2kg, 6.0kg with printer), Rapid mixer granulator (table top 1/5 L capacity), Double cone blender (5L Capacity), Remi stirrers, Machine Hooper, Sifter, Tablet Deduster, Paste Kettle, Jet Claerner, Semi-Automatic Cap Sealing Machine, Online Inspection, Turn Table, Labelling machine, Semi-Automatic Ropp Cap Sealing Machine and screw capping machine, Tube Filling Machine Prototype, Laboratory Microscopes(40X and 100X), pH meter , Bulk density and Tapped density tester, Friabilator, Vernier calipers, Micrometer screw gauge, Scale, Hot plate with magnetic stirrer, UV Analyser (Make: Perkin elmer/shimadzu/Thermo), Mortor and Pessel (Type: Silica, SS-316L, Agate, Granite), Halogen Moisture Analyzer, Seive Shaker, Seive meshes (All grade levels like 100, 150, 200, 250 etc,..), Motor grinder, analytical balance, Pipettes (1mL, 2mL, 5 ml/10 ml), water bath, Desicattor, Dissolution Apparatus, Lab equipped with Fume Hoods, Glassware for Lab, Burrette stand with white tile, Various Cartridges, Sodium Metal in kerosine for testing, Various types of cleaning material, chemicals, cleaning equipment, Half Face Mask, Full Face Mask, Safety Goggles, Safety Shoes, Gum Boots, Chemical Absorbent, Self-Contained Breathing Apparatus, PVC Apron, Gloves(Nitrile, {Heat, acid, chemical} resistant, washing etc..), Lab Coat, Surgical Gloves (in Microbiology), Eye washer with sprinkler/ Manual bottle eye washer, Co2type Fire Extinguisher, ABC Type Fire Extinguisher, Material Safety Data Sheet, Various Safety Signage

Grand Total Course Duration: _376 Hours _00__ Minutes

(This syllabus/ curriculum has been approved by Life Sciences Sector Skill Development Council.)


Trainer Prerequisites for Job role: “Production/ Machine Operator- Life Sciences” mapped to Qualification Pack: “LFS/ Q 0207 Ver1.0”

Sr. No.

Area Details

1 Job Description To deliver accredited training service, mapping to the curriculum detailed above, in accordance with the Qualification Pack “LFS/Q0207 Ver1.0”.

2 Personal Attributes Aptitude for conducting training, and pre/ post work to ensure competent, employable candidates at the end of the training. Strong communication skills, interpersonal skills, ability to work as part of a team; a passion for quality and for developing others; well-organised and focused, eager to learn and keep oneself updated with the latest in the mentioned field.

3 Minimum Educational Qualifications

10+2/ ITI

4a Domain Certification Certified for Job Role: “Production/ Machine Operator” mapped to QP: “LFS/Q 0207 Ver1.0”. Minimum accepted score is 80% as per LSSSDC guidelines.

4b Platform Certification Recommended that the Trainer is certified for the Job Role: “Trainer”, mapped to the Qualification Pack: “SSC/Q1402”. Minimum accepted score is 80% as per LSSSDC guidelines.

5 Experience Preferably Minimum Four (4) years’ experience in life sciences (Pharmaceutical/ Biopharmaceutical) manufacturing occupation for non-trained and non-qualified talent

Or

Minimum Two (2) years’ experience with Production/ Machine Operator- Life Sciences Level-4 qualified


Annexure: Assessment Criteria

Assessment Criteria for Production/ Machine Operator- Life Sciences Job Role Production/ Machine Operator- Life Sciences Qualification Pack LFS/ Q 0207 Ver1.0 Sector Skill Council Life Sciences Sector Skill Development Council

Sr. No. Guidelines for Assessment

1 Criteria for assessment for each Qualification Pack will be created by the Sector Skill Council. Each Performance Criteria (PC) will be assigned marks proportional to its importance in NOS. SSC will also lay down proportion of marks for Theory and Skills Practical for each PC

2 The assessment for the theory part will be based on knowledge bank of questions created by the SSC

3 Individual assessment agencies will create unique question papers for theory part for each candidate at each examination/training centre (as per assessment criteria laid out in Qualification Pack)

4 Individual assessment agencies will create unique evaluations for skill practical for every student at each examination/training centre based on the assessment criteria laid out in qualification pack

5 To pass the Qualification Pack , every trainee should score a minimum of 70% aggregate in all NOS and a minimum of 50% in every NOS

6 In case of successfully passing only certain number of NOS's, the trainee is eligible to take subsequent assessment on the balance NOS's to pass the Qualification Pack


Marks Allocation

Total Marks (600)

Out Of Theory Skills

Practical

LFS/N0213 (Prepare

machines and accessories for

the manufacturing

process)

PC1. ensure that the machine, surrounding areas and classified areas are clean, dry, sterilised (wherever required) and fit for use as per the SOP to avoid contamination and highlight the risk if any

100

4 2 2

PC2. set up machines at the beginning of the batch processing to ensure proper working order and refer to the machine history received from the supervisor/colleague

4 2 2

PC3. perform testing procedures to ensure that machines work optimally to carry out production activities

4 2 2

PC4. ensure that the approach path from the input storage area to storage area for output is free of obstructions to transportation

4 2 2

PC5. select the correct material to be loaded 4 2 2

PC6. ensure that the material is from a respective batch and is checked by the concerned supervisor and approved by the QA team

4 2 2

PC7. assemble the machinery properly 4 2 2

PC8. set critical parameters for the machinery (cycle time, temperature, pressure, ampere load, spray rate, etc.) as per the company’s SOP

4 2 2

PC9. keep all the accessories like cleaning brush, levers, release agent, etc. ready

4 2 2

PC10. monitor machines during every procedure to ensure optimum performance

4 2 2

PC11. perform random tests to ensure accuracy and maintain online documentation for the same along with justifications for any wrong entries, if any

4 2 2

PC12. coordinate with maintenance teams for preventive maintenance

4 2 2

PC13. ensure stocks of required materials are ready and available at all times

4 2 2

PC14. ensure that the compound/material to be fed is approved by the laboratory as per SOP and record the receipt details like product name, batch name and operator name

4 2 2


Marks Allocation

Total Marks (600)


Practical

PC15.match the batch code/item code , AR.No of each compound/material with the batch code on the job schedule given by the planning department, ensuring FIFO and further record the name, shelf life and quantities during documentation

4 2 2

PC16. measure/weigh the raw material/compound as per the desired specifications (shape, size and weight) and return the unused material to warehouse with the appropriate label

4 2 2

PC17. ensure, by visual inspection, that the compound is of desired quality (free of contamination/bloom), and reach out to the supervisor for rejection control if disparities exist

4 3 3

PC18. ensure housekeeping/safety in the manufacturing area as per the SOP

4 2 2

PC19. maintain and clean the machines before and after batch processing

4 2 2

PC20. use lifting equipment such as forklift/trolleys while lifting heavy materials to avoid physical injury

4 2 2

PC21. ensure that the lift/ejection/slide/pneumatic valve mechanism of the machinery is properly functioning

4 2 2

PC22. ensure that signs indicating hot surfaces are put up wherever necessary

4 2 2

PC23. adhere to all safety norms (like wearing protective gloves, shoes)

4 2 2

PC24. comply with health, safety, environment guidelines, regulations in accordance with international/national standards or organizational SOP

4 3 3

Total 100 50 50

LFS/N0214 (Perform

manufacturing operations)

PC1. handle the chemicals, materials and compounds appropriately to avoid contamination

100

12 6 6

PC2.conduct pre-start checks 12 6 6

PC3. start the equipment safely and perform 'dry runs' to warm hydraulics and components to operating temperature before production, as required

10 5 5

14

Marks Allocation

Total Marks (600)


Practical

PC4. load the identified material in the correct pattern as per the SOP to minimize material overflow/wastage/excess flash

10 5 5

PC5. ensure smooth running of machines and the pressure and temperature is maintained in the machines as per the specifications

12 6 6

PC6. adhere to the SOPs and guidelines for maintaining quality

12 6 6

PC7. maintain both online and offline records in the log books and other documentation required as per GMP and GDP like – breakdown time, daily manufacturing record, yield report, etc

6 3 3

PC8. take appropriate safety steps while carrying out manufacturing operations

8 2 6

PC9. carry out status labelling 4 2 2

PC10. provide support for line clearance before the next batch is produced

4 2 2

PC 11. perform broad level in- process checks and report results to supervisor

4 2 2

PC 12. ensure and confirm correctness of online process parameters

6 3 3

Total 100 48 52

LFS/N0103 (Ensure

cleanliness in the work area)

PC1.inspect the area while taking into account various surfaces

100

4 2 2

PC2.identify the material requirements for cleaning the areas inspected, by considering risk, time, efficiency and type of stain

5 2 3

PC3.ensure that the cleaning equipment is in proper working condition

5 2 3

PC4.select the suitable alternatives for cleaning the areas in case the appropriate equipment and materials are not available and inform the appropriate person

4 2 2

PC5.plan the sequence for cleaning the area to avoid re-soiling clean areas and surfaces

4 2 2

PC6.inform the affected people about the cleaning activity

4 2 2

PC7.display the appropriate signage for the work being conducted

4 2 2

PC8.ensure that there is adequate ventilation 5 2 3


Marks Allocation

Total Marks (600)


Practical

for the work being carried out

PC9.wear the personal protective equipment required for the cleaning method and materials being used

4 2 2

PC10.use the correct cleaning method for the work area, type of soiling and surface

4 2 2

PC11.deal with accidental damage, if any, caused while carrying out the work

4 2 2

PC12.report to the appropriate person any difficulties in carrying out work

4 2 2

PC13.identify and report to the appropriate person any additional cleaning required that is outside one’s responsibility or skill

4 2 2

PC14.ensure that there is no oily substance on the floor to avoid slippage

4 2 2

PC15.ensure that no scrap material is lying around

4 2 2

PC16.maintain and store housekeeping equipment and supplies

4 2 2

PC17.follow workplace procedures to deal with any accidental damage caused during the cleaning process

4 2 2

PC18.ensure that, on completion of the work, the area is left clean and dry and meets requirements

4 2 2

PC19.return the equipment, materials and personal protective equipment that were used to the right places making sure they are clean, safe and securely stored

5 2 3

PC20.dispose the waste garnered from the activity in an appropriate manner

5 2 3

PC21.dispose of used and un-used solutions according to manufacturer’s instructions, and clean the equipment thoroughly

5 2 3

PC22.maintain schedules and records for housekeeping duty

5 2 3

PC23.replenish any necessary supplies or consumables

5 2 3

Total 100 46 54

LFS/N0102 (Carry out

reporting and

PC1.report data/problems/incidents as applicable in a timely manner 100

10 5 5

PC2.report to the appropriate authority as 10 5 5


Marks Allocation

Total Marks (600)


Practical

documentation) laid down by the company

PC3.follow reporting procedures as prescribed by the company

10 5 5

PC4.identify documentation to be completed relating to one’s role

10 5 5

PC5.record details accurately in an appropriate format

10 5 5

PC6.complete all documentation within stipulated time according to company procedure

10 5 5

PC7.ensure that the final document meets regulatory and compliance requirements

10 5 5

PC8.make sure documents are available to all appropriate authorities to inspect

10 5 5

PC9.respond to requests for information in an appropriate manner whilst following organizational procedures

10 5 5

PC10.inform the appropriate authority of requests for information received

10 4 6

Total 100 49 51

LFS/N0215 (Carry out

broad level quality checks

before, in-process and

post manufacturing)

PC1.ensure that total range of checks are regularly and consistently performed

100

10 5 5

PC2.check that the products, materials and equipment meet the requirements for production

10 5 5

PC3.use appropriate measuring instruments, equipment, tools, accessories etc. as required

10 5 5

PC4.identify non-conformities to quality assurance standards

10 5 5

PC5.identify potential causes of non-conformities to quality assurance standards

10 5 5

PC6.identify impact on final product due to non-conformance to company standards

15 7 8

PC7.evaluate the need for action to ensure that problems do not recur

10 5 5

PC8.suggest corrective action to address problems

12 6 6

PC9.review effectiveness of corrective action 13 6 7

Total 100 49 51

LFS/N0101 PC1.observe and comply with the company’s current health, safety and security policies

100 10 5 5


Marks Allocation

Total Marks (600)


Practical

(Maintain a healthy, safe

and secure working

environment in the life sciences

facility)

and procedures

PC2.while carrying out work, use appropriate safety gears like head gear, masks, gloves and other accessories as mentioned in the guidelines

10 5 5

PC3.report any identified breaches in health, safety, and security policies and procedures to the designated person

10 5 5

PC4.responsible for maintaining discipline at the shop-floor/ production area

10 5 5

PC5.identify and correct any hazards that the individual can deal with safely, competently and within the limits of their authority

10 5 5

PC6.adhere and comply to storage and handling guidelines for hazardous material

10 5 5

PC7.identify and recommend opportunities for improving health, safety, and security to the designated person

10 5 5

PC8. complete any health, safety and security activities like safety drills and prepare records legibly and accurately

10 4 6

PC9.report any hazards that the individual is not competent to deal with to the relevant person in line with organizational procedures and warn other people who may be affected

10 4 6

PC10. follow the company’s emergency procedures promptly, calmly, and efficiently

10 5 5

Total 100 48 52

Grand Total 600 600 290 310

Percentage Weightage 48% 52%

Minimum Pass Percentage to Qualify 70%


Life Sciences Sector Skill Council # 13, 3rd Floor, Palam Marg, Vasant Vihar, New Delhi-110057

Documents

Model Curriculum - Livelihoodlivelihoods.rajasthan.gov.in/content/dam/livlihood...Rapid mixer granulator (table top 1/5 L capacity), Double cone blender (5L Capacity), Remi stirrers,